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ADVENTRX Announces Results From ANX-514 Bioequivalence Study
Date:5/7/2009

ly following infusion of study drug (i.e., during the first hour of treatment) in patients receiving ANX-514 relative to those receiving Taxotere, but, at 10 minutes after the completion of infusion, docetaxel blood-levels were comparable and remained so through the end of the observation period. The Company is analyzing these short-term increased levels, which were the reason ANX-514 was outside the bounds established by the FDA for determining bioequivalence. Analyzing blood-levels at all time points beginning 10 minutes after the completion of drug administration, pharmaceutical equivalence of ANX-514 and Taxotere was observed.

The bioequivalence study of ANX-514 was an open-label, two-period, randomized, crossover comparison of ANX-514 and Taxotere in patients with advanced cancer potentially sensitive to docetaxel. The primary objective was demonstrating the pharmacokinetic equivalence of ANX-514 and Taxotere and determining the safety of a single dose of ANX-514 was a secondary objective. On Day 1, patients were dosed with either ANX-514 or Taxotere and, on Day 22, were dosed with the other drug. Patients were premedicated with corticosteroids prior to treatment on Day 1 and on Day 22. The FDA has indicated that this single bioequivalence study, should it demonstrate pharmacokinetic equivalence between ANX-514 and Taxotere, would provide sufficient data to support an NDA.

Pharmacokinetic equivalence was assessed by a statistical comparison of both the areas under the curve (AUC) and maximum plasma concentrations (Cmax) and determined based on federal regulations and FDA guidance regarding bioequivalence studies. If the upper and lower bounds of the AUC ratio's and the Cmax ratio's 90% confidence interval ranged from 0.80 to 1.25, ANX-514 and Taxotere would be considered to have equivalent pharmacokinetics. Pursuant to the study's protocol and statistical analysis plan, data from 31 patients who received both
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SOURCE ADVENTRX Pharmaceuticals, Inc.
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